Method and apparatus for phrenic stimulation detection

• US 9,352,160 B2
• Filed: 03/23/2015
• Issued: 05/31/2016
• Est. Priority Date: 02/14/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Brooke, M. Jason
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/665,690
• Publication Number:
  US 20150190642A1
• Time in Patent Office: 435 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/1107 Measuring contraction of parts of the body, e.g. organ, muscle apparatus for measuring work or force in general G01L
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4029 for evaluating the peripheral nervous systems A61B5/24 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3684 for stimulating the heart at multiple sites of the ventricle or the atrium
• CPC Class Codes: A61N 1/36842 Multi-site stimulation in the same chamber
• CPC Class Codes: A61N 1/36843 Bi-ventricular stimulation
• CPC Class Codes: A61N 1/3706 Pacemaker parameters stimulation threshold A61N1/371
• CPC Class Codes: A61N 1/371 Capture, i.e. successful stimulation
• CPC Class Codes: A61N 1/3712 Auto-capture, i.e. automatic adjustment of the stimulation threshold
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

Approaches for characterizing a phrenic stimulation threshold, a cardiac capture threshold, a maximum device parameter, and a minimum device parameter are described. A plurality of cardiac pacing pulses can be delivered by using a cardiac pacing device, a pacing parameter of the plurality of cardiac pacing pulses being changed between delivery of at least some of the pulses. One or more sensor signals can be evaluated to detect stimulation of the phrenic nerve by one or more of the plurality of cardiac pacing pluses. The evaluation of the one or more sensor signals and the pacing parameter can be compared to determine if a phrenic stimulation threshold is at least one of higher than a maximum device parameter and lower than a minimum device parameter.

Claims

1. A method, comprising;

delivering a pulse with a predetermined pulse energy;

determining if the delivered pulse produced phrenic stimulation;

if it is determined that the delivered pulse did not produce phrenic stimulation, performing a capture threshold test without performing a phrenic stimulation threshold test; and

if it is determined that the delivered pulse did produce phrenic stimulation, performing a capture threshold test and a phrenic stimulation threshold test.

2. The method of claim 1, wherein the predetermined pulse energy corresponds to a cardiac pacing device capability limit.

3. The method of claim 1, wherein the predetermined pulse energy corresponds to a programmed cardiac pacing device limit.

4. The method of claim 1, wherein a cardiac pacing device includes a plurality of electrode combinations where each electrode combination defines a pacing vector, the method comprising performing the method for each of two or more pacing vectors.

5. The method of claim 4, further comprising:

for each of the two or more pacing vectors, displaying on a display of a patient external device an indication of whether the pulse produced phrenic stimulation; and

for each of the two or more pacing vectors, displaying on the display of the patient external device an indication of a capture threshold as determined by the capture threshold test.

6. The method of claim 1, wherein the capture threshold test comprises:

delivering a plurality of cardiac pacing pulses; and

changing a pacing parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of cardiac pacing pulses until a capture threshold is detected.

7. The method of claim 6, wherein the pacing parameter comprises an amplitude and/or width of a cardiac pacing pulse, and wherein the pacing parameter is reduced between delivery of at least some of the plurality of cardiac pacing pulses until the capture threshold is detected.

8. The method of claim 6, wherein the phrenic stimulation threshold test comprises:

delivering a plurality of cardiac pacing pulses;

changing a pacing parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of cardiac pacing pulses until the phrenic stimulation threshold is detected.

9. The method of claim 8, wherein at least some of the plurality of cardiac pacing pulses are part of both the capture threshold test and the phrenic stimulation threshold test.

10. The method of claim 1, wherein the phrenic stimulation threshold test comprises:

delivering a plurality of cardiac pacing pulses; and

changing a pacing parameter for one or more of the plurality of cardiac pacing pulses between delivery of at least some of the plurality of cardiac pacing pulses until a phrenic stimulation threshold is detected.

11. The method of claim 10, wherein the pacing parameter comprises an amplitude and/or width of a cardiac pacing pulse, and wherein the pacing parameter is reduced between delivery of at least some of the plurality of cardiac pacing pulses until the until the phrenic stimulation threshold is detected.

12. The method of claim 10, wherein the pacing parameter comprises an amplitude and/or width of a cardiac pacing pulse, and wherein the pacing parameter is increased between delivery of at least some of the plurality of cardiac pacing pulses until the until the phrenic stimulation threshold is detected.

13. The method of claim 1, wherein determining if the pulse produced phrenic stimulation comprises monitoring an output of an accelerometer secured relative to a patient.

14. The method of claim 1, wherein the method is performed at least in part by an implantable cardiac pacing device.

15. The method of claim 1, wherein the method is performed at least in part by a patient external device.

16. A method, comprising;

(a) selecting an electrode combination of a plurality of electrode combinations;

(b) delivering a pulse with a predetermined pacing pulse energy via the selected electrode combination;

(c) determining if the pulse produced phrenic stimulation;

(d) if it is determined that the pulse did not produce phrenic stimulation, perform a capture threshold test using the selected electrode combination without performing a phrenic stimulation threshold test;

(e) if it is determined that the pulse did produce phrenic stimulation, perform a capture threshold test and a phrenic stimulation threshold test using the selected electrode combination; and

(f) repeating steps (a)-(e) for at least one other electrode combination of the plurality of electrode combinations.

17. The method of claim 16, further comprising:

displaying a capture threshold as determined by the capture threshold test for the selected electrode combination on a display of a patient external device.

18. The method of claim 16, further comprising:

If the phrenic stimulation threshold test was performed, displaying a phrenic stimulation threshold as determined by the phrenic stimulation threshold test for the selected electrode combination on a display of a patient external device.

19. A medical apparatus, comprising;

a pulse generator for generating pulses at selectable pulse energy;

a controller operatively coupled to the pulse generator, the controller configured to;

(a) instruct the pulse generator to deliver a pulse with a predetermined pacing pulse energy;

(b) determine if the delivered pulse produced phrenic stimulation;

(c) if it is determined that the delivered pulse did not produce phrenic stimulation, perform a capture threshold test without performing a phrenic stimulation threshold test; and

(d) if it is determined that the delivered pulse did produce phrenic stimulation, perform a capture threshold test and a phrenic stimulation threshold test.

20. The medical apparatus of claim 19, further comprising:

a switch for selectively connecting the pulse generator to a selected electrode combination of a plurality of electrode combinations; and

wherein the controller is configured to repeat (a)-(d) for at least one other electrode combination of the plurality of electrode combinations.